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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 30262E
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model 30262e because a lot number was not provided by the customer. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ extension set male luer was damaged and leaked during use. The following information was provided by the initial reporter: "male luer bent. " "did you experience any adverse events? no, just leaking. ".
 
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Brand NameBD ALARIS SMARTSITE EXTENSION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12555454
MDR Text Key274058561
Report Number9616066-2021-52144
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number30262E
Device Catalogue Number30262E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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